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Clinical Trials/NCT03766802
NCT03766802UnknownNot Applicable

Effects of Wearable Technology and Smart Mobile Phone Applications Based Exercise Training and Supervised Exercise Training in Patients With Type 2 Diabetes

Marmara University1 site in 1 country102 target enrollmentStarted: February 5, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
102
Locations
1
Primary Endpoint
Glycated Hemoglobin (HbA1c)

Study Overview

Brief Summary

The purpose of this study is to estimate the extent to which supported exercise training through wearable technology and mobile application affects glycemic control in comparison to supervised exercise training in patients with Type-2 Diabetes.

Detailed Description

The purpose of this study is to estimate the extent to which supported exercise training through wearable technology and mobile application affects glycemic control in comparison to supervised exercise training in patients with Type-2 Diabetes.

Inclusion Criteria:

  • Age 18-65
  • No other chronic condition
  • No exercise training background Block Randomization according to age and sex.

Confirmatory Outcome

  • Glycated Hemoglobin (HbA1c)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age 18-65 No other chronic condition No exercise training background

Exclusion Criteria

  • •Exclusion criteria are a set of predefined condition that is used to identify subjects who will not be included or who will have to withdraw from a research study after being included.

Arms & Interventions

Wearable watch training group.

Active Comparator

Aerobic exercises Strengthening exercises Stretching exercises Balance exercises Dose was increased as person is able to tolerate. Form:intervention is trackable and notifiable if patients don't exercise with smartwatch.

Frequency:3/week Duration:12 weeks Dosage:Dose was increased as person is able to tolerate.

Intervention: Wearable watch training group. (Behavioral)

Mobile application training group.

Active Comparator

Aerobic exercises Strengthening exercises Stretching exercises

Balance exercises Form:intervention is trackable and notifiable if patients don't exercise with smartphone Dose was increased as person is able to tolerate. Frequency:3/week Duration:12 weeks Dosage:Dose was increased as person is able to tolerate.

Intervention: Mobile application training group. (Behavioral)

Supervised exercise training group

Sham Comparator

Aerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist

Intervention: Supervised exercise training group (Behavioral)

Outcomes

Primary Outcomes

Glycated Hemoglobin (HbA1c)

Time Frame: 5 minutes

It used as a diagnostic test for diabetes and as assessment test for glycemic control in people with diabetes. It comes in unit of percentage identifies how much glucose is carried on a certain amount of blood. We included people who have 6.5% or more which is the cut point for The International Diabetes Federation and the American College of Endocrinology.

Secondary Outcomes

  • Six-Minute Walk Test(6 min)
  • International physical activity questionnaire short form (IPAQ)(7 days)
  • The forced vital capacity(10 minutes)
  • Forced expiratory volume(10 minutes)
  • Assessment of muscle strength with isokinetic device(15 minutes)
  • Accelerometer(7 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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